Abuse-Deterrent Opioids: - PowerPoint Presentation

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Abuse-Deterrent Opioids:

FDA’s Role and Emerging Challenges

Jeanne Ireland

Principal, Ireland Strategies, LLC

2015 CWAG Annual MeetingSlide3

The Opioid Epidemic

Some progress being made, but devastating effects of epidemic continue

Each day, 44 Americans die from overdoses of prescription painkillers, including opioids

In 2013, nearly 2 million Americans abused prescription pain medications and more than 16,000 died

In five of the western states, over 80 painkiller prescriptions are written per 100 residents – the second highest rate in the nation. Even in those western states with the lowest national rates, 50-70 prescriptions are written per 100 residents

2012 was the first drop/leveling off of prescription overdose deaths since the 1990s

AGs and States have played a leading role in addressing opioids abuse and overdose

Use of a broad range of approaches, including prescription drug monitoring programs, naloxone access, cracking down on “pill mills,” advocacy for abuse-deterrent technologies

I

ntroduction of legislation in 31 states this year alone relating to abuse-deterrent opioidsSlide4

Abuse-Deterrent Opioids – a New Tool for Reducing Abuse

Abuse-deterrent opioids (ADOs) – opioids in formulations that are designed to deter abuse by one or more routes

“Abuse-deterrent” = more difficult to abuse, not abuse-proof

Current products have properties that deter abuse, including through the often lethal routes of snorting or injecting

May never be able to completely prevent abuse since product has to deliver pain relief to patient – current products can still be abused by swallowing more pills than prescribed

But, still an important element of a comprehensive strategy for reducing misuse and abuse

Shift in landscape – now technological, as well as medical, law-enforcement, and policy tools available

Emergence of ADO products presents new challenges for policymakers, including standard-setting, labeling, data, access, and costSlide5

The Federal Role in Combatting the Epidemic

Many agencies with different mandates related to opioid abuse, including:

Office of

National

Drug

Control Policy– education and training

Department of Justice/Drug Enforcement Agency – oversight of controlled substances, enforcement

Department of Health and Human Services

National Institutes of Health/National Institute on Drug Abuse - research

Centers for Disease Control and Prevention – epidemiological studies

Substance Abuse and Mental Health Services Administration/Indian Health Service/Veterans Administration/Bureau of Prisons – provider education, support for PDMPs

Centers for Medicare

and Medicaid Services- coverage, oversight of utilization

Food and Drug Administration – drug approval standards, labeling and other safety measuresSlide6

FDA’s Role in Regulating Opioids

Sets standards for the approval of opioids, i.e., what type of data is required to demonstrate safety and effectiveness, analysis of risks vs. benefits

Sets standards for the approval of brand and generic ADOs – additional element of assessment of AD properties

Can require drug manufacturers to develop education materials and train practitioners on appropriate use and to conduct

postmarket

studies

Determines what “labeling” a drug will carry

Informs patients, providers, and

payors

for which conditions/uses the drug is approved, how it should be used, safety information

Determines the type of claims that can be made by drug sponsor in marketing and promoting the product

Can mandate changes to labels of approved products if FDA becomes aware of new safety information Slide7

FDA’s Regulation of ADOs:

Multiple and Competing Considerations

FDA’s vision: “…a future in which most or all opioid medications are available in formulations that are less susceptible to abuse than the formulations that are on the market today.”

Incentivize ADO development

Incentivize progressively stronger AD properties

Set realistic expectations about limitations of current technologies

Ensure access to lower-cost generics

Maintain access to pain relief for patients in needSlide8

Current FDA Efforts

Since 2010, approved four opioids with AD properties

In 2012, required manufacturers to educate providers and patients on appropriate prescribing and safe use

In 2013, ordered safety changes to labels of certain opioids to clarify their use for severe

pain and

for patients

for whom other lower-risk pain medications a

re

not

appropriate. Also required manufacturers to conduct additional

postmarket

studies

Issued guidance for the evaluation and labeling of branded ADOs (draft in January 2013, final in April 2015) -- sets the bar for types and strength of data needed to achieve progressively stronger AD labeling

Laboratory testing

Pharmacokinetic studies

Human abuse potential

studies

Postmarket

data on effect in real-world

settingSlide9

Remaining ADO Policy Decisions For FDA

Setting the bar for approval of generic ADOs – guidance expected as soon as this year

Refuse approval of new opioids without AD properties?

Withdrawal of existing products without AD properties?

Additional labeling?

Complexities

Bar will keep shifting as technologies improve

Continuing need for dataSlide10

Remaining ADO Policy Decision Outside of FDA’s Purview - Access

Reimbursement decisions by payors

, including CMS, can impact patient access to ADOs

Recent study by

Avalere

found Medicare Part D plans place greater restrictions on patient access to ADOs than to non-abuse-deterrent generics opioids

Considerations

Cost

Need for dataSlide11

Conclusions

Goal remains the same – reduction in abuse

ADOs offer an important new tool, but much more needs to be done

Critical policy decisions still ahead offer opportunities for continued engagementSlide12